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Primary Care and Adolescent Immunization for Rochester (PCAIR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581347
First Posted: December 27, 2007
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Los Angeles
Results First Submitted: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: Adolescent Immunizations
Preventive Care
Intervention: Other: outreach services

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The target population was teens with birthdates between 7/1/92 & 6/30/97 at 8 practices in Rochester, NY. 2 methods were used to identify eligible adolescents;(1)2 insurance plans in the region provided a list of all their pts at these practices. (2)2 practices added to the list all teens who made a visit within 2 years of the study start date.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We preformed a stratified random sample, allocating all adolescents to either an intervention or standard of care group (using SAS 9.1). We stratified by practice, age and gender. For families with 2 or more eligible siblings, we assigned all siblings to the same group. Healthcare providers were unaware of group assignment.

Reporting Groups
  Description
Outreach

The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.

Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.

Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.

Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.

Standard of Care Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.

Participant Flow:   Overall Study
    Outreach   Standard of Care
STARTED   3839   3707 
COMPLETED   3839   3707 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Outreach

The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.

Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.

Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.

Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments.

Standard of Care Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
Total Total of all reporting groups

Baseline Measures
   Outreach   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 3839   3707   7546 
Age, Customized 
[Units: Participants]
     
11 years old   784   757   1541 
12 years old   743   701   1444 
13 years old   714   686   1400 
14 years old   781   758   1539 
15 years old   817   805   1622 
Gender 
[Units: Participants]
     
Female   1903   1849   3752 
Male   1936   1858   3794 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Receipt of Adolescent Immunization at End of Study Period (Tdap, Menactra, HPV)   [ Time Frame: 15 months ]

2.  Secondary:   Receipt of a Well Child Visit Within a 12 Month Period   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Szilagyi
Organization: University of Rochester Medical Center
phone: 585-275-5798
e-mail: peter_szilagyi@urmc.rochester.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00581347     History of Changes
Other Study ID Numbers: PCAIR
OPP-P-2006-24
First Submitted: December 19, 2007
First Posted: December 27, 2007
Results First Submitted: August 12, 2010
Results First Posted: October 1, 2010
Last Update Posted: September 23, 2016